FDA Approves Eyenuk System for Retinal Scanning

Medical device company Eyenuk Inc. on Wednesday announced U.S. Food and Drug Administration clearance to market its diabetic retinopathy detection software. Called EyeArt, the artificial intelligence system will be used by health care providers to detect mild to vision-threatening diabetic retinopathy, a complication of diabetes and a leading cause of blindness among the elderly. Retinal images are scanned and checked against a database of other retinal images for the disease. Also, the scans can check for other diseases including glaucoma, age-related macular degeneration, risk of stroke, cardiovascular risk and Alzheimer’s disease, Eyenuk said. An autonomous version of the screening process will likely be covered by insurance starting next year, the Woodland Hills company said; results would not need to be interpreted by an ophthalmologist. “This is great news to over 30 million Americans living with diabetes, especially those who may have vision-threatening diabetic retinopathy,” Dr. Kaushal Solanki, chief executive of Eyenuk, said in a statement. “This historical FDA clearance is our first major milestone enabled by our prospective, multi-center pivotal clinical trial which took us years to plan and complete.” A total of 942 individuals participated in Eyenuk’s clinical trial — screenings picked up the disease 97 percent of the time, the company said, and 90 percent of participants did not need eye dilation to get such results.